(57 days)
Not Found
No
The summary describes image processing techniques for motion correction but does not explicitly mention or describe the use of AI or ML algorithms. The "Mentions AI, DNN, or ML" field is "Not Found".
No
The device is described as aiding in the detection, localization, and diagnosis of diseases and disorders, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders." It also describes how both the MR and PET components provide information for diagnostic purposes. Additionally, the "Device Description" calls it a "combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner."
No
The device is described as a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner, which are hardware components. While it includes software, it is an integral part of a larger hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
- This device performs imaging: The SIGNA PET/MR system is an imaging device that uses Magnetic Resonance and Positron Emission Tomography to visualize the internal structure and function of the human body in vivo (within the living body).
- The intended use describes imaging and diagnosis based on imaging: The intended use clearly states the system is used to produce images and measure the distribution of radiopharmaceuticals to aid in the detection, localization, and diagnosis of diseases and disorders. This is achieved through imaging, not through the analysis of biological samples.
Therefore, the SIGNA PET/MR system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.
PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
Product codes
OUO
Device Description
The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a detachable patient table and both the acquisition and processing workstations with associated software.
The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil and a transmit/receive whole body radiofrequency coil. The system includes patient adaptable RF shimming capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisitions. The PET subsystem supports Time of Flight (ToF) coincidence detection. The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The modifications to this system include the MotionFree Brain software feature, which allows users the flexibility to correct patient head motion using the acquired PET data from the exam, without the need of external tracking devices, additional MR data, or other motion tracking data schemes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD), Positron Emission Tomography (PET)
Anatomical Site
whole body, human body, brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
An external reader evaluation study was performed for MotionFree Brain. The retrospective blind study involved board-certified readers who were asked to evaluate randomly labeled cases that were reconstructed with and without MotionFree Brain. The readers were blinded to feature use (e.g. whether feature was enabled or disabled), report case history, as well as to the assessments made by the other readers. The readers were asked to complete an assessment, including additional commentary, and report their preference on the pair of image series presented.
Summary of Performance Studies
Non-clinical tests have been summarized in the verification and validation testing. The testing was completed with passing results per the pass/fail criteria defined in the test cases. Performance testing on phantoms as part of non-clinical testing demonstrated MotionFree Brain achieved performance claims for Quantitation, Temporal Resolution, and Spatial Accuracy.
An external reader evaluation study was performed for MotionFree Brain. The retrospective blind study involved board-certified readers who were asked to evaluate randomly labeled cases that were reconstructed with and without MotionFree Brain. Verification documents, validation documents, and test reports have been provided for more details. Testing demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device. No new questions of safety and effectiveness were raised during nonclinical testing.
Clinical testing confirms that MotionFree Brain can be used safely and effectively in a clinical setting.
Key Metrics
Not Found
Predicate Device(s)
SIGNA PET/MR (K163619)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
January 20, 2022
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GE Medical Systems, LLC % Mr. Brian Zielski Regulatory Affairs Leader 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K213709
Trade/Device Name: SIGNA PET/MR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO Dated: November 22, 2021 Received: November 24, 2021
Dear Mr. Zielski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Julie Sullivan Associate Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K213709
Device Name SIGNA PET/MR
Indications for Use (Describe)
The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.
PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 22, 2021 |
|---|---|
| Submitter: | GE Medical Systems, LLC |
| 3200 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Primary Contact: | Brian R. Zielski |
| Regulatory Affairs Leader | |
| Phone: 262-227-3596 | |
| Email: brian.zielski@ge.com | |
| Secondary Contact: | Andrew Menden |
| Senior Regulatory Affairs Manager | |
| Phone: 262-308-5719 | |
| Email: andrew.menden@ge.com | |
| Device Trade Name: | SIGNA PET/MR |
| Common / Usual Name: | Magnetic Resonance Diagnostic Device / Positron |
| Emission Tomography (PET) System | |
| Classification Name: | Emission Computed Tomography System 21 CFR |
| 892.1200 | |
| Product Code: | OUO |
| Predicate Device(s): | SIGNA PET/MR (K163619) |
| Device Description: | The GE SIGNA PET/MR system is a combined Magnetic |
| Resonance Diagnostic Device (MRDD) and Positron | |
| Emission Tomography (PET) scanner. The system is | |
| designed for whole body oncology, neurology and | |
| cardiology examinations. The SIGNA PET/MR system | |
| provides simultaneous acquisition of high resolution | |
| metabolic and anatomic information from the two major | |
| components of each system (MR and PET). Additional | |
| components of the system include: a detachable patient | |
| table and both the acquisition and processing | |
| workstations with associated software. |
The SIGNA PET/MR includes a 3.0T superconducting
magnet, gradient coil and a transmit/receive whole body
radiofrequency coil. The system includes patient
adaptable RF shimming capabilities. The SIGNA PET |
| | detectors are integrated into the MR bore. This allows for
simultaneous, precisely aligned whole body MR and PET
acquisitions. The PET subsystem supports Time of Flight
(ToF) coincidence detection. The SIGNA PET/MR
software is used for patient management, data
management, scan control, image reconstruction and
image archival and evaluation. All images conform to
DICOM imaging format requirements. |
| | The modifications to this system include the MotionFree
Brain software feature, which allows users the flexibility to
correct patient head motion using the acquired PET data
from the exam, without the need of external tracking
devices, additional MR data, or other motion tracking data
schemes. |
| Indications for Use: | The SIGNA PET/MR system combines magnetic
resonance diagnostic devices (MRDD) and Positron
Emission Tomography (PET) scanners that provide
registration and fusion of high resolution physiologic and
anatomic information, acquired simultaneously and
isocentrically. The combined system maintains
independent functionality of the MR and PET devices,
allowing for single modality MR and / or PET imaging. |
| | These systems are intended to be utilized by
appropriately trained health care professionals to aid in
the detection, localization, and diagnosis of diseases and
disorders. MR is intended to produce transverse, sagittal,
coronal and oblique cross-sectional MR images,
spectroscopic images and/or spectra, and displays the
internal structure and/or function of the human body.
Other physical parameters derived from the images
and/or spectra may also be produced. Depending on the
region of interest, approved contrast agents may be used,
as described in their labeling. This system may also be
used for imaging during interventional procedures when
performed with MR compatible devices, such as MR safe
biopsy needles. |
| | PET images and measures the distribution of PET
radiopharmaceuticals in humans to aid the physician in
determining various metabolic (molecular) and
physiologic functions within the human body for
evaluation of diseases and disorders such as, but not
limited to, cardiovascular disease, neurological disorders
and cancer. |
| | The combined system utilizes the MR for radiation-free
attenuation correction maps for PET studies. The system |
| | provides inherent anatomical reference for the fused PET
and MR images due to precisely aligned MR and PET
image coordinate systems. |
| Comparison of
Technological
Characteristics: | The SIGNA PET/MR with the proposed software feature
employs the same fundamental technology as the
predicate device. |
| | The SIGNA PET/MR has been modified to include the
MotionFree Brain feature. The user interface provides
operators of the system with an option for enabling this
feature. MotionFree Brain derives head motion
information from the PET data; there is no need for
external tracking devices, additional MR data, or
additional PET data collection. The feature measures
and incorporates the rigid-body motion information into
the PET reconstruction, correcting the position of each
coincidence event to account for patient head motion. |
| | These technological differences do not raise any different
questions regarding safety and effectiveness. Both
devices must allow for an effective method to setup an
appropriate scan prescription. The performance data
described in this submission include results of both bench
testing and clinical testing that show the performance of
the SIGNA PET/MR compared to the predicate device. |
| Summary of Nonclinical
Testing: | The following quality assurance measures were applied
to the development of the device:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Verification (functional testing for subsystem and
system integration)
• Validation (simulated use testing) |
| | Non-clinical tests have been summarized in the
verification and validation testing. The testing was
completed with passing results per the pass/fail criteria
defined in the test cases. This supports
substantial equivalence to its predicate because the
software feature was developed under quality assurance
Design Controls. Performance testing on phantoms as
part of non-clinical testing demonstrated MotionFree
Brain achieved performance claims for Quantitation,
Temporal Resolution, and Spatial Accuracy. |
| | |
| Summary of Clinical
Testing: | An external reader evaluation study was performed for
MotionFree Brain. The retrospective blind study involved
board-certified readers who were asked to evaluate
randomly labeled cases that were reconstructed with and
without MotionFree Brain. Verification documents, validation documents, and test
reports have been provided for more details. Testing
demonstrated that the device is as safe, as effective, and
performs as well as or better than the predicate device.
No new questions of safety and effectiveness were raised
during nonclinical testing. |
| | The readers were blinded to feature use (e.g. whether
feature was enabled or disabled), report case history, as
well as to the assessments made by the other readers.
The readers were asked to complete an assessment,
including additional commentary, and report their
preference on the pair of image series presented. |
| | Clinical testing confirms that MotionFree Brain can be
used safely and effectively in a clinical setting. |
| Conclusion Drawn from
Performance Testing: | The SIGNA PET/MR with the modified software feature
has the same intended use as the predicate. This 510(k)
submission includes information on the technological
characteristics of the proposed software feature, as well
as performance data demonstrating that the feature is as
safe and effective as the predicate, and does not raise
different questions of safety and effectiveness. |
| | In conclusion, GE Healthcare considers the SIGNA
PET/MR to be at least as safe and effective, and its
performance is substantially equivalent to the predicate
device. |
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5
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6
Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are three water droplet-like shapes surrounding the circle, one at the top and one on each side. The logo is simple and recognizable, representing the company's brand identity.